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Completed

NCT Number: NCT01298583

Ankle Tracking Training in Stroke

The purpose of this study is to compare the improvement in ankle control and brain activation in subjects with stroke resulting from two different forms of telerehabilitation: tracking training, emphasizing accurate movements, versus movement training, involving simple movements.

Hypotheses:

1. The Track group will show greater improvement in ankle range of motion compared to the Move group. 2. The Track group will show greater improvement in ankle tracking accuracy and greater changes in fMRI (increase in relative volume of activation for ipsilesional sensorimotor cortex, increase in laterality index, and decrease in blood-oxygen-level-dependent (BOLD) signal intensity index) compared to Move group. 3. The Track group will show greater improvement in tracking accuracy at an untrained joint (knee) compared to the Move group. 4. The Track group will show greater improvement in standing balance. 5. The Track group will show greater improvement in walking speed and ankle dorsiflexion during gait compared to the Move group.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Single stroke with an ischemic infarct.
  • Between 18 and 85 years of age.
  • Time since stroke onset must be >6 months.
  • Cannot be receiving any rehabilitation therapy.
  • Impaired ankle dorsiflexion/plantarflexion but at least 10 degrees of active motion.
  • Cognition level must be at least 24 out of 30 on the Mini-Mental Examination 7. Able to ambulate at least 100 feet independently. training.

Exclusion criteria

  • Cannot have any neuromuscular disorder other than stroke that impairs ankle motion.
  • Cannot have an executive function score on Stroop Interference Test of <37.
  • Cannot have a score on the Beck Depression Inventory of >10.
  • Cannot have ataxia, apraxia, receptive aphasia, hemi-neglect, or severe visual field cut .
  • Cannot be pregnant nor have indwelling metal or medical devices incompatible with fMRI.

Treatment and study plan

ankle tracking training

Behavioral

one group will use the ankle for tracking, the other group will use the ankle for simple movement

Primary outcomes

  1. ankle range of motion

    Time frame: Measurement at pretest, posttest and followup

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Important dates

Study start
2007
Primary completion
2008
Study completion
2010
First posted
Feb 17, 2011
Registry last updated
Nov 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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